WO2017102018A1

WO2017102018A1 - Multi-part package labeling scheme for clinical supplies

Info

Publication number: WO2017102018A1
Application number: PCT/EP2015/080374
Authority: WO
Inventors: Ann King
Original assignee: R.P. Scherer Technologies, Llc
Priority date: 2015-12-17
Filing date: 2015-12-17
Publication date: 2017-06-22
Also published as: AR106997A1; TW201722787A

Abstract

A method and label for handling a package containing clinical trial supplies. The package has a pre-printed, multi-part label affixed to a first side of the package, where the multi-part label includes a main, first portion and a peelable, second portion, where each portion has pre-printed information corresponding to the clinical supplies contained in the package. The second portion is removed from the affixed multi-part label and re-affixed to a second side of the package, such that the information corresponding to the clinical supplies printed on the second portion is visible from the second side of the package when the package is stacked with other packages in a manner that obscures from view the first portion of the first side of the package. The invention eliminates the need to copy kit and patient identifiers by hand onto the second side of the package, thereby reducing the risk of errors.

Description

MULTI-PART PACKAGE LABELING SCHEME FOR CLINICAL SUPPLIES

BACKGROUND

Field of the Invention

[0001 ] The present invention relates to package labeling and, more specifically, to labeling schemes for packages containing clinical supplies.

Description of the Related Art

[0002 ] This section introduces aspects that may help facilitate a better understanding of the invention. Accordingly, the statements of this section are to be read in this light and are not to be understood as admissions about what is prior art or what is not prior art.

[ 0003] A rectilinear package containing supplies for a clinical trial typically has a label affixed to one side of the package, where, in a 'blinded fashion' where required, the clinical trial label identifies the contents of the enclosed clinical supplies. Such clinical trial labels have to comply with GMP (Good Manufacturing Practice) and the relevant country's regulatory requirements. This often means there can be a substantial amount of text on a label, and for ease of access pharmaceutical companies or organizations providing the medication or other clinical supplies will typically apply the label to the largest side of the package. The production of clinical trial labels is a highly controlled process with each step being double checked to ensure accuracy. In addition to the text, a clinical label typically contains numeric codes corresponding to a kit identifier that identifies the package as being allocated to a particular treatment group in the clinical trial and a patient identifier that identifies the patient for whom the package is intended. These identifiers are key to ensuring that the appropriate patient gets the appropriate medication for his/her treatment group.

[ 0004 ] The identifiers become even more important if multiple packages are dispensed to patients during the course of the clinical trial when treating chronic conditions. Once a patient is randomized to a particular treatment, it is critical to ensure that, at every dispensing visit, the package dispensed to the patient contains the appropriate medication for that treatment group.

[ 0005] When clinical trial labels are applied to the largest sides of packages, and the packages are stacked on a shelf for storage at the clinical site, the labels are often obscured from view by other packages. To address this issue, individuals responsible for handling those packages frequently use a marker to write the kit and patient identifiers by hand on the side of each package that is visible in the package stack. Since these identifiers are typically long multi-digit numbers, this manual copying can result in an incorrect number being written onto the side of a package.

[0006] Thus, there is a potential serious risk to patient safety. If the wrong number is written onto the side of a package, then the wrong medication could be dispensed to the patient. From the published literature, error rates vary, but individual studies have reported inpatient medication error rates of 4.8% to 5.3% and, in another study, prescribing errors for inpatients occurred 12.3 times per 1000 patient admissions. A recent study in the American Heart Journal evaluated previously reported results of medication dispensing errors during clinical trials. Although the reported incidence of patients receiving at least one incorrect package was between 0.77% and 1.04%, most of these incidents were due to transcription errors, where the incorrect kit identifier was entered into the case report form.

[0007 ] The regulatory authorities have recognized that medication errors during dispensing represent a significant burden to public health. The EMA (European Medicines Agency) has issued a Good Practice Guide document for consultation which includes guidance on labelling and packaging that can mitigate the occurrence of dispensing errors with a particular section devoted to the types of medication errors that can occur in clinical trials. See "Good practice guide on risk minimisation and prevention of medication errors," EMA/606103/2014, 14 April 2015, the teachings of which are incorporated herein by reference.

SUMMARY

[0008 ] In one embodiment, the present invention is a method for handling a clinical supply package containing clinical supplies for a clinical trial. The clinical supply package is provided with a pre-printed, multi-part label affixed to a first side of the package, wherein (i) the multi-part label comprises a main, first portion and a peelable, second portion and (ii) each portion comprises pre-printed information corresponding to the numeric identity of the clinical supplies contained in the package. The second portion is removed from the affixed multi-part label and re-affixed to a second side of the package (e.g., the side of the package that is visible when packages are stacked one on top of the other), such that the information corresponding to the clinical supplies on the second portion is visible from the second side of the package. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Embodiments of the invention will become more fully apparent from the following detailed description, the appended claims, and the accompanying drawings in which like reference numerals identify similar or identical elements.

[0010] FIGs. 1 and 2 are a plan view and a perspective view, respectively, of a multi-part, pre-printed, clinical label according to one embodiment of the invention;

[0011] FIG. 3 is a perspective view of the clinical label of FIGs. 1 and 2 after the backing layer has been removed;

[0012] FIG. 4 is a perspective view of a package containing clinical supplies, where the clinical label of FIG. 3 has been initially affixed to a first side of the package;

[0013] FIG. 5 is an exploded view of the clinical label of FIG. 3 showing the peelable portion after it has been removed from the clinical label;

[0014] FIG. 6 is a perspective view of the labeled package of FIG. 4 with the clinical label of FIG. 5 affixed to the first side of the package with the main portion in place and the now-peeled portion re-affixed to a second, different side of the package; and

[0015] FIG. 7 is a perspective view of a stack of multiple instances of the labeled packages of FIG. 6.

DETAILED DESCRIPTION

[0016] Detailed illustrative embodiments of the present invention are disclosed herein. However, specific structural and functional details disclosed herein are merely representative for purposes of describing example embodiments of the present invention. The present invention may be embodied in many alternate forms and should not be construed as limited to only the embodiments set forth herein. Further, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments of the invention.

[0017] As used herein, the singular forms "a," "an," and "the," are intended to include the plural forms as well, unless the context clearly indicates otherwise. It further will be understood that the terms "comprises," "comprising," "includes," and/or "including," specify the presence of stated features, steps, or components, but do not preclude the presence or addition of one or more other features, steps, or components. It also should be noted that in some alternative implementations, the functions/acts noted may occur out of the order noted in the figures. For example, two figures shown in succession may in fact be executed substantially concurrently or may sometimes be executed in the reverse order, depending upon the functionality/acts involved.

[ 0018 ] FIGs. 1 and 2 are a plan view and a perspective view, respectively, of a multi-part, pre-printed, clinical label 100 according to one embodiment of the invention. The clinical label 100 contains a main portion 1 10 and a peelable portion 120. The main portion 110 contains text and other printed information needed to conform to industry standards and guidelines for clinical supply packages, including a clinical protocol (study) identifier 102 and a patient kit identifier 104. The peelable portion 120 also includes customizable printed information, including the clinical protocol (study) identifier 102a and the patient kit identifier 104b.

[0019] In this particular embodiment, the information printed on the peelable portion 120 is written at a 90-degree angle compared to the information printed on the main portion 110. This can make it easier for an individual to identify the package from different viewing orientations. Note that, in other embodiments, the information printed on the peelable portion 120 can be aligned with the information printed on the main portion 110.

[0020 ] As shown in FIG. 2, the main portion 1 10 of the clinical label 100 comprises a printable layer 1 12 on top of an adhesive layer 114, while the peelable portion 120 comprises a printable layer 122 on top of a first adhesive layer 124 on top of a non-adhesive layer 126 on top of a second adhesive layer 128. Underlying both the main portion 110 and the peelable portion 120 is a removable backing layer 130. Note that the thicknesses of the layers in the perspective views of FIG. 2 and other figures are not drawn to scale, but are depicted as being much thicker for ease of explanation.

[0021] As shown in FIG. 2, there is a perforation 132 between the printable layer 112 of the main portion 1 10 and the printable layer 122 of the peelable portion 120 that enables the printable layer 122 to be removed along with the first adhesive layer 124 from the rest of the clinical label 100.

[0022] In some, but not necessarily all embodiments, the printable layers 112 and 122 are made of the same material, such as a suitable paper or plastic material; the adhesive layers 114, 124, and 128 are all made of the same suitable adhesive material; and the layers 126 and 130 are made of the same suitable plastic material. In alternative embodiments the different layers may be made from different materials. Suitable label products that may be used for the clinical label 100 include E22035839 4" X 2" White (PE) Piggyback Labels from Vista Labels of Stockport, England. The non-adhesive layer 126 may be made of transparent plastic or any other suitable non-adhesive material. [ 0023 ] To affix the clinical label 100 to a clinical supply package, the backing layer 130 is removed, thereby exposing the adhesive layers 1 14 and 128 and enabling the clinical label 100 to be affixed to a first side of the package.

[ 0024 ] FIG. 3 is a perspective view of the clinical label 100 of FIGs. 1 and 2 after the backing layer 130 has been removed, and FIG. 4 is a perspective view of a six-sided, rectilinear package 400 containing clinical supplies (not shown), where the clinical label 100 of FIG. 3 has been initially affixed to a first side 402 of the package 400.

[ 0025 ] FIG. 4 represents the labeled package 400 as it arrives at a clinical site from a pharma company or organization or other clinical supplier. When an individual at the clinical site stacks the labeled package 400 for storage with other labeled packages, the individual can remove the peelable portion 120 from the affixed clinical label 100 and re-affix the now-peeled portion 120 onto the side of the package 400 that will be exposed and visible in the package stack.

[ 0026] FIG. 5 is an exploded view of the clinical label 100 of FIG. 3 showing the peelable portion 120 after it has been removed from the clinical label 100. Note that the first adhesive layer 124 is removed along with the printable layer 122, thus exposing the non-adhesive layer 126.

[ 0027 ] FIG. 6 is a perspective view of the labeled package 400 of FIG. 4 with the clinical label 100 of FIG. 5 affixed to the first side 402 of the package 400 with the main portion 1 10 in place and the now-peeled portion 120 re-affixed to a second, different side 404 of the package 400. Note that the remaining portion of the clinical label 100 corresponding to the peeled portion 120 comprises the non-adhesive layer 126 and a (typically) transparent adhesive layer 128. As such, any printing on the package underlying that portion of the clinical label 100 will be visible after the peelable portion 120 has been removed. Note that, in alternative embodiments, the non-adhesive layer 126 and/or the adhesive layer 128 are not transparent.

[ 0028 ] FIG. 7 is a perspective view of a stack 700 of multiple instances of the labeled packages 400 of FIG. 6. As shown in FIG. 7, although the clinical labels 100 with their main portions 1 10 intact are obscured from view, the re-affixed, peeled portions 120 are exposed and visible in the stack 700. As such, when it is time for an individual to remove a particular clinical supply package from the stack, the individual can locate the appropriate package 400 using the accurate information printed on the corresponding peeled portion 120 without the risk that that information was incorrectly copied by hand from the main portion 1 10 of the clinical label 100. [0029] Although the invention has been described in the context of the clinical label 100 of FIGs. 1 and 2 which has a main portion 1 10 and one peelable portion 120, in other embodiments, labels of the invention may have multiple peelable portions that can be individually and selectively removed from the label and re-affixed to different sides of the package to enable the package to be stacked in different orientations and still enable viewing of information such as the kit and patient identifiers.

[0030] It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain embodiments of this invention may be made by those skilled in the art without departing from embodiments of the invention encompassed by the following claims.

[0031 ] In this specification including any claims, the term "each" may be used to refer to one or more specified characteristics of a plurality of previously recited elements or steps. When used with the open-ended term "comprising," the recitation of the term "each" does not exclude additional, unrecited elements or steps. Thus, it will be understood that an apparatus may have additional, unrecited elements and a method may have additional, unrecited steps, where the additional, unrecited elements or steps do not have the one or more specified characteristics.

[0032 ] The use of figure numbers and/or figure reference labels in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as necessarily limiting the scope of those claims to the embodiments shown in the corresponding figures.

[ 0033] It should be understood that the steps of the exemplary methods set forth herein are not necessarily required to be performed in the order described, and the order of the steps of such methods should be understood to be merely exemplary. Likewise, additional steps may be included in such methods, and certain steps may be omitted or combined, in methods consistent with various embodiments of the invention.

[ 0034] Reference herein to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the invention. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. The same applies to the term "implementation."

Claims

CLA1MS What is claimed is:

1. A method for handling a clinical supply package containing clinical supplies for a clinical trial, the method comprising:

(a) providing the clinical supply package with a pre-printed, multi-part label affixed to a first side of the package, wherein:

the multi-part label comprises a main, first portion and a peelable, second portion; and each portion comprises pre-printed information corresponding to the clinical supplies contained in the package;

(b) removing the second portion from the affixed multi-part label; and

(c) re-affixing the second portion to a second side of the package, such that the information corresponding the clinical supplies on the second portion is visible from the second side of the package.

2. The method of claim 1 , wherein step (a) comprises affixing the multi-part label onto the first side of the package.

3. The method of claim 2, wherein step (a) further comprises removing a backing layer from the multi-part label to expose adhesive material of the multi-part label.

4. The method of any of claims 1-3, wherein the first side is a top surface of the package, and the second side is a side surface of the package adjacent to the top surface.

5. The method of any of claims 1-4, wherein the package can be stacked with other packages in a way that obscures from view the first portion on the first side of the package, while providing a view of the second portion on the second side of the package.

6. The method of any of claims 1-5, wherein the method eliminates a need to write the information by hand on the second side of the package.

7. The method of any of claims 1-6, wherein:

the first portion of the multi-part label comprises:

a printable layer; and

an adhesive layer below the printable layer; and

the second portion of the multi-part label comprises:

a printable layer; a first adhesive layer below the printable layer;

a non-adhesive layer below the first adhesive layer; and

a second adhesive layer below the non-adhesive layer; and

the printable layer and the first adhesive layer of the second portion are peelable from the multi-part label.

8. The method of claim 7, wherein the non-adhesive layer of the second portion is a transparent plastic layer.

9. The method of any of claims 1-8, wherein the multi-part label further comprises one or more additional peelable, pre-printed portions that are removable from the affixed multi-part label and re-affixable to one or more additional sides of the package.

10. The method of claim 1 , wherein:

the first side is a top surface of the package, and the second side is a side surface of the package adjacent to the top surface;

the package can be stacked with other packages in a way that obscures from view the first portion on the first side of the package, while providing a view of the second portion on the second side of the package;

the method eliminates a need to write the information by hand on the second side of the package;

the first portion of the multi-part label comprises:

a printable layer; and

an adhesive layer below the printable layer; and

the second portion of the multi-part label comprises:

a printable layer;

a first adhesive layer below the printable layer;

a non-adhesive layer below the first adhesive layer; and

a second adhesive layer below the non-adhesive layer; and

1 1. The method of claim 10, wherein step (a) comprises:

(a1 ) removing a backing layer from the multi-part label to expose adhesive material of the multi-part label; and

(a2) affixing the multi-part label onto the first side of the package.

12. The method of claim 10, wherein the non-adhesive layer of the second portion is a transparent plastic layer.

13. The method of claim 10, wherein the multi-part label further comprises one or more additional peelable, pre-printed portions that are removable from the affixed multi-part label and re-affixable to one or more additional sides of the package.

14. A pre-printed, multi-part label for a clinical supply package containing clinical supplies for a clinical trial, the label comprising:

a main, first portion; and

a peelable, second portion, wherein each portion comprises pre-printed information corresponding to the clinical supplies contained in the package, such that:

the label is configured to be affixed to a first side of the package;

the second portion is configured to be removed from the affixed multi-part label; and the second portion is configured to be re-affixed to a second side of the package, such that the information corresponding the clinical supplies on the second portion is visible from the second side of the package.

15. The label of claim 14, wherein the label comprises a removable backing layer that can be removed from the label to expose adhesive material of the label.

16. The label of any of claims 14-15, wherein:

the first portion of the label comprises:

a printable layer; and

an adhesive layer below the printable layer; and

the second portion of the label comprises:

a printable layer;

a first adhesive layer below the printable layer;

a non-adhesive layer below the first adhesive layer; and

a second adhesive layer below the non-adhesive layer; and

17. The label of claim 16, wherein the non-adhesive layer of the second portion is a transparent plastic layer.

18. The label of any of claims 14-17, wherein the label further comprises one or more additional peelabie, pre-printed portions that are removable from the affixed label and re-affixable to one or more additional sides of the package.